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FDA 510(k)

FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT

K-Number: K971047 · 1997-06-20

ApplicantNexa Orthopedics, Inc.
Decision Date1997-06-20
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Nexa Orthopedics, Inc.. It received FDA 510(k) clearance on 1997-06-20 under 510(k) number K971047. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT?

FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT is a medical device that received FDA 510(k) clearance on 1997-06-20. The listed applicant is Nexa Orthopedics, Inc.. The 510(k) number is K971047.

When did FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT receive FDA 510(k) clearance?

FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT received FDA 510(k) clearance on 1997-06-20, under 510(k) number K971047.

Who is the listed applicant for FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT?

The FDA 510(k) record lists Nexa Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT?

The FDA product code for FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT is KWD.

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Other records listing Nexa Orthopedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K072710NEXFIX COMPRESSION PINK071147NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEMK070688NEXFIX COMPRESSION STAPLEK060386NEXA CARPO METACARPAL IMPLANTK060071NEXA COMPRESSION SCREWK053408NEXA BONE PLATE AND SCREW SYSTEM

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Related Devices (Code: KWD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity MedicalK222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLCK201393restor3d MTP ImplantRestor3D, Inc.K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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